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Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation

Title
Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
Authors
Lee, So-RyoungLee, Young SooPark, Ji-SuckCha, Myung-JinKim, Tae-HoonPark, JunbeomPark, Jin-KyuLee, Jung-MyungKang, Ki-WoonShim, JaeminUhm, Jae-SunKim, JunKim, ChangsooKim, Jin-BaePark, Hyung WookJoung, BoyoungChoi, Eue-Keun
Ewha Authors
박준범
SCOPUS Author ID
박준범scopus
Issue Date
2019
Journal Title
YONSEI MEDICAL JOURNAL
ISSN
0513-5796JCR Link

1976-2437JCR Link
Citation
YONSEI MEDICAL JOURNAL vol. 60, no. 3, pp. 277 - 284
Keywords
Atrial fibrillationnon-vitamin K antagonist oral anticoagulantdrug labelingdose
Publisher
YONSEI UNIV COLL MEDICINE
Indexed
SCIE; SCOPUS; KCI WOS scopus
Document Type
Article
Abstract
Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5 +/- 9.2 years; 56.0% were men; and the mean CHA(2)DS(2)-VASc score was 3.3 +/- 1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (>= 75 years), women, and had a lower body weight (<= 60 kg), renal dysfunction (creatinine clearance <= 50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.
DOI
10.3349/ymj.2019.60.3.277
Appears in Collections:
의과대학 > 의학과 > Journal papers
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